PMID- 34060462
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20240322
IS  - 2245-1919 (Electronic)
IS  - 2245-1919 (Linking)
VI  - 68
IP  - 6
DP  - 2021 May 28
TI  - Peroral versus intravenous post-operative antibiotics after surgery for 
      complicated appendicitis: protocol for a cluster-randomised cluster-crossover 
      non-inferiority study.
LID - A12200917 [pii]
AB  - INTRODUCTION: Complicated appendicitis increases the risk of post-operative 
      intra-abdominal abscess. Treatment of complicated appendicitis is usually a 
      post-operative course of intravenous antibiotics. A study is needed to confirm 
      the results of retrospective studies showing that a post-operative course of oral 
      antibiotics is not inferior to intravenous antibiotics after laparoscopic surgery 
      for complicated appendicitis. METHODS: The Per oral versus Intravenous 
      Postoperative Antibiotics after surgery for complicated appendicitis (PIPA) trial 
      will be a prospective, multicentre, cluster-randomised cluster-crossover 
      non-inferiority study designed to test whether a three-day post-operative course 
      of oral antibiotics is non-inferior to a three-day post-operative course of 
      intravenous antibiotics as standard care after laparoscopic surgery for 
      complicated appendicitis in regards to the risk of post-operative intra-abdominal 
      abscess formation within 30 days. Participating hospitals will either be 
      randomised to a six-month period with an oral antibiotic regime followed by a 
      six-month period with an intravenous antibiotic regime for the post-operative 
      treatment after laparoscopic surgery for complicated appendicitis, or to a 
      six-month period with an intravenous antibiotic regime followed by a six-month 
      period with an oral antibiotic regime for post-operative treatment after 
      laparoscopic surgery for complicated appendicitis. CONCLUSIONS: The primary 
      outcome will be the incidence of intra-abdominal abscess by post-operative day 
      30. FUNDING: none. TRIAL REGISTRATION: The study was approved by the Danish Data 
      Protection Agency and by the National/Regional Committee on Health Research 
      Ethics.
CI  - Articles published in the DMJ are "open access". This means that the articles are 
      distributed under the terms of the Creative Commons Attribution Non-commercial 
      License, which permits any non-commercial use, distribution, and reproduction in 
      any medium, provided the original author(s) and source are credited.
FAU - Mohamud, Ahmed Abdirahman
AU  - Mohamud AA
AD  - ahmm@regionsjaelland.dk.
FAU - Kleif, Jakob
AU  - Kleif J
FAU - Gogenur, Ismail
AU  - Gogenur I
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20210528
PL  - Denmark
TA  - Dan Med J
JT  - Danish medical journal
JID - 101576205
RN  - 0 (Anti-Bacterial Agents)
SB  - IM
MH  - Humans
MH  - *Abdominal Abscess/drug therapy
MH  - Anti-Bacterial Agents/therapeutic use
MH  - Appendectomy/adverse effects
MH  - *Appendicitis/drug therapy/surgery
MH  - Multicenter Studies as Topic
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Equivalence Trials as Topic
MH  - Cross-Over Studies
EDAT- 2021/06/02 06:00
MHDA- 2021/08/19 06:00
CRDT- 2021/06/01 08:43
PHST- 2021/06/01 08:43 [entrez]
PHST- 2021/06/02 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
AID - A12200917 [pii]
PST - epublish
SO  - Dan Med J. 2021 May 28;68(6):A12200917.